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Atovaquone
Chemical Name | ：Atovaquone |
Category | ：insect resistant |
Specification | ：USP |
HS Code | ：29147000.90 |
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Structure Formula | ： |
CAS Number | ：95233-18-4 |
Molecular Formula | ：C22H19ClO3 |
Usage | ：Is the activity of several kinds of parasite |
Items | Standard |
|---|---|
Appearance | Yellow powder |
Solubility | Freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran ; slightly soluble in ethylacetate;insoluble in water. |
Identification | A)Infrared Absorption B)The retention time of the major peak corresponds to that of standard by HPLC |
Water | ≤1.0 % |
Residue on ignition | ≤1.0 % |
Heavy metals | ≤10ppm |
Residual solvents | Methanol≤2000ppm Chloroform≤60ppm Dichloromethane≤600ppm Acetonitrile≤410ppm |
Related substance | RRT=0.63≤0.5% RRT=0.89≤0.3% RRT=1.8≤0.5% Related compound A≤1.0% Any other impurity≤0.2% Total other impurity≤1.0% Total impurities≤1.5% |
Assay(HPLC) | 97.5~101.5% |
1， Argentinian National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)
2， Australian?Therapeutic?Goods?Administration (TGA)
3， Belgian Federal Agency for Medicines and Health Products
Agence Fédérale des Médicaments et des Produits de Santé(AFMPS)
Federaal Agentschap voor Geneesmiddelen enGezondheidsproducten (FAGG)
4， Canadian?Health?Products and?Food?Branch?Inspectorate(HPFBI)
5， Taiwan?Food and?Drug?Administration?(TFDA)
7， Czech State Institute for Drug Control
Státní ústav pro Kontrolu Lé?iv (SúKL)
8， Czech?Institute for?State?Control of?Veterinary?Biologicals?and?Medicines (ISCVBM)
9， Danish?Health and?Medicines?Authority (DHMA)
10， Finnish?Medicines?Agency (FIMEA)
11， French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
12， 13， German Federal Ministry of Health * 14， Icelandic?Medicines?Agency?(IMA) 20， Indonesian?National?Agency for?Drug and?Food?Control (NADFC) 21， Health?Products?Regulatory?Authority?(HPRA) 22， Italian Medicines Agency 23， Japanese?Pharmaceuticals and?Medical?Devices?Agency(PMDA) 24， Korea (Republic of)?Ministry of?Food and?Drug?Safety?(MFDS) 25， Malaysian?National?Pharmaceutical?Control?Bureau?(NPCB) 26， Dutch Health Care Inspectorate* 27， (Medsafe) 28， Norwegian?Medicines?Agency?(NOMA) 29， Polish?Main?Pharmaceutical?Inspectorate (MPI) 30， Romanian?National?Agency for?Medicines and?MedicalDevices (NAMMD) 31， South African?Medicines?Control?Council?(MCC) 32， Spanish Agency of Medicines and Medical Devices?* Agencia Espa?ola de Medicamentos y Productos Sanitarios(AEMPS) 33， Swedish?Medical?Products?Agency?(MPA) 34， (MHRA) 36， U.S.?Food and?Drug?Administration (US FDA) 37， European Directorate for the Quality of Medicines & HealthCare （EDQM） 38， European Medicines Agency（EMA） 39， World Health Organization（WHO）
Bundesministerium für Gesundheit (BMG)
Agenzia Italiana del Farmaco (AIFA)
Inspectie voor de Gezondheidszorg (IGZ)